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RECRUITING Not applicable ClinicalTrials.gov

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Sponsor: Dartmouth-Hitchcock Medical Center • ClinicalTrials.gov ID: NCT07428629

Registry updated: 2026-08-28
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Description

The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are: * Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants? * Does CBT-I for UC impact insomnia severity and sleep continuity? Participants will: * Answer questionnaires online before and after treatment * Complete an online daily sleep diary before, during, and after treatment * Participate in 5 telehealth treatment visits over 7-8 weeks * Participate in 5-10-minute phone calls between treatment visits

Interventions

  • CBT-I UC (Behavioral)
    This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.

Eligibility criteria

Inclusion Criteria: * Active UC based on PRUCSI * Insomnia Severity Index score \> 8 and SOL or WASO \> 30 minutes * Stability of sleep \& UC meds for \> 3 months * Access to internet or cell phone service sufficient for telehealth Exclusion Criteria: * PHQ-9 depression score \> 15 * GAD-7 anxiety score \> 15 * Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder) * Current alcohol or substance abuse * Current opioid use for pain control * Current systemic corticosteroid use * Current pregnancy or nursing * Ileostomy or colostomy * Diagnosis of seizure disorder * Diagnosis of sleep apnea * Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen * Night shift, rotating shift work, or frequent travel outside of time zone * Residence in a state where we cannot conduct telehealth visits

Conditions

Insomnia Ulcerative Colitis

Locations

  • Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record